Regulatory and Start Up Specialist - Remote

Overview

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.

In Short

• Responsible for site activation readiness within assigned country/sites.
• Preparation of Clinical Trial Application Forms and submission dossiers.
• Interaction with Competent Authorities and Ethics Committees.
• Maintenance of project plans and regulatory intelligence tools.
• Preparation of study-specific start-up plans.
• Collaboration with site CRAs for communication alignment.
• Management of essential document collection for site activation.
• Customization of Patient Information Sheets and Informed Consent Forms.
• Maintain communication with key functions for project status.
• Act as SME for site activation data points.

Requirements

• Bachelor’s degree in life sciences or related field.
• 1 year or more as a Regulatory or Start Up specialist.
• Strong communication and organizational skills.
• Experience with computerized information systems.
• Fluency in English.

Benefits

• Opportunity to work in a growing organization.
• Contribute to impactful cancer therapies.
• Employee contributions are valued and nurtured.